Clinical Trial: Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
Brief Summary: This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.
Detailed Summary:
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: Partial response (reduction in 30% of tumor volume) or greater response within 12 months from the implant procedure. [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change of the patient's Humphrey visual field testing [ Time Frame: 5 years ]
- Potential toxicities associated with interstitial seed placement [ Time Frame: 5 years ]
- Progression free survival [ Time Frame: 5 years ]
- The effect of the treatment on quality of life evaluations (patient reported outcomes) [ Time Frame: 5 years ]
- The cost-utility of the treatment arm (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: September 22, 2011
Date Started: October 2011
Date Completion: December 2020
Last Updated: January 6, 2017
Last Verified: January 2017
